CN116172750A

CN116172750A - Delivery device and valve clip system

Info

Publication number: CN116172750A
Application number: CN202111426544.0A
Authority: CN
Inventors: 邢怒安
Original assignee: Hanxin Medical Technology Shenzhen Co ltd
Current assignee: Hanxin Medical Technology Shenzhen Co ltd
Priority date: 2021-11-27
Filing date: 2021-11-27
Publication date: 2023-05-30

Abstract

The invention relates to the technical field of medical appliances, and discloses a conveying device and a valve clamping system. The conveying device comprises a conveying sheath pipe and a control piece; the conveying sheath tube comprises a connecting end and a control end; the control piece comprises a control rod, a control handle and a connector, wherein the control rod movably penetrates through the conveying sheath pipe, the control rod comprises a hollow pipe and a plunger rod movably penetrating through the hollow pipe, the control handle is connected to one end of the hollow pipe and one end of the plunger rod and extends out of the control end of the conveying sheath pipe, the connector is detachably connected to the other end of the hollow pipe, the connector is used for being connected with a clamping piece close to the end, the control handle is used for driving the hollow pipe and the plunger rod to move so that the connector is connected with or disconnected from the hollow pipe, and the clamping piece close to or unfolded from the fixing seat. The conveying device and the valve clamping system can be used in valve repair operation, and can solve the technical problems that the conveying device is easy to break and inconvenient to assemble and disassemble in the existing valve repair operation.

Description

Delivery device and valve clip system

Technical Field

The invention relates to the technical field of medical equipment, in particular to a conveying device and a valve clamping system.

Background

Mitral insufficiency is one of the most common valve pathologies at present, and the main causes are mitral annulus dilation, chordae tendineae insufficiency, mitral mucous degeneration, leaflet prolapse, rheumatic valvular disease, ischemic lesions, etc. Mitral valve direct vision plasty and prosthetic valve replacement are the most effective methods for treating mitral insufficiency, but because the operation requires technical support of extracorporeal circulation, the trauma to the human body is relatively large, and the complications and mortality rate are relatively high for elderly patients and patients with more complications.

Medical staff and scientific researchers in various countries have recently explored transcatheter mitral valve repair techniques, and main interventional treatment methods include annuloplasty, negative pressure suction suturing, mitral valve clamping, and the like, wherein the curative effect of mitral valve clamping is most reliable. Mitral valve clamping delivers an implantable valve clamp to the vicinity of the mitral valve through an atrial septum puncture, and clamps the free edges of the anterior and posterior leaflets, resulting in good coaptation of the leaflets at the end systole and reduced regurgitation. The traditional valve clamping system controls the opening and closing of the clamping pieces through the silk threads, the silk threads have good flexibility, and the opening and closing angles of the clamping pieces are easy to adjust by utilizing the silk threads. However, the wires are at a greater risk of breakage during use, have low reliability, and are not easily removed from the clip after clamping is complete.

Disclosure of Invention

The invention aims to provide a conveying device and a valve clamping system, which can solve the technical problems that the conveying device is easy to break and inconvenient to assemble and disassemble in the existing valve repair operation.

In a first aspect, the present invention provides a delivery device and a valve clip system for delivering a valve clip, the valve clip comprising a holder and a proximal clip disposed on the holder and being foldable or deployable relative to the holder, the delivery device comprising:

the conveying sheath tube comprises a connecting end and a control end;

the control part comprises a control rod, a control handle and a connector, wherein the control rod is movably arranged in the conveying sheath tube in a penetrating manner, and comprises a hollow tube and an inserted rod movably arranged in the hollow tube in a penetrating manner; the control handle is connected to one end of the hollow tube and one end of the inserted link and extends out from the control end of the conveying sheath tube; the connector is detachably connected to the other end of the hollow tube and is used for connecting the proximal clamping piece; the control handle is used for driving the hollow tube and the inserted link to move so that the connector is connected with or disconnected from the hollow tube, and the proximal clamping piece is folded or unfolded relative to the fixing seat.

In an embodiment, the connector comprises a first connecting portion, the control rod comprises a second connecting portion, and the control handle is used for driving the inserted rod to move in the first connecting portion and the second connecting portion so that the hollow tube is connected with or disconnected from the connector.

In an embodiment, the first connecting portion is a connecting pipe head with a hollow interior, the second connecting portion is an elastic arm arranged at one end of the hollow pipe connected to the connecting head, and the elastic arm can extend into the connecting pipe head and be clamped with the connecting pipe head;

the control handle is used for controlling the inserted link to move along the axial direction of the hollow pipe so as to enable the inserted link to be switched between a locking state and a switching state, wherein when the inserted link is in the locking state, the elastic arm is clamped with the connecting pipe head under the abutting of the inserted link; when the inserted link is in an unlocking state, the inserted link is far away from the elastic arm, and the elastic arm and the connecting tube head can be separated along the axial direction of the inserted link.

In an embodiment, the elastic arm includes two opposite elastic pieces, and the two elastic pieces are in a tapered structure along a direction pointing to a free end of the elastic piece;

the inserting rod can extend into the space between the two elastic sheets and is abutted against the inner wall of the elastic sheet, so that the elastic sheet is abutted against the inner wall of the connecting pipe head.

In an embodiment, a first clamping structure is arranged on the inner wall of the connecting tube head, and a second clamping structure matched and clamped with the first clamping structure is arranged on the outer wall of the elastic piece.

In an embodiment, the first connecting portion is a first half pipe, the second connecting portion is a second half pipe, a limit groove and a limit flange capable of being matched and clamped are formed at the edges of the first half pipe and the second half pipe respectively, a hollow pipe structure is formed after the first half pipe and the second half pipe are combined, and the limit groove and the limit flange are clamped along the axial direction of the hollow pipe;

the control handle is used for controlling the inserted link to move along the axial direction of the hollow pipe so as to enable the inserted link to be switched between a locking state and a switching state, wherein when the inserted link is in the locking state, the inserted link stretches into the hollow pipe formed by the first half pipe and the second half pipe in a butt joint mode, and the first half pipe and the second half pipe are locked along the radial direction of the inserted link; when the inserted link is in an unlocking state, the inserted link is far away from the first half pipe and the second half pipe, and the first half pipe and the second half pipe can be separated along the radial direction of the inserted link.

In an embodiment, the edges of the first half pipe and the second half pipe are in a smooth transition S-shaped structure.

In one embodiment, the connector includes a securing ring for connecting the proximal clip.

In an embodiment, the delivery device includes two sets of control members, the delivery sheath includes two sets of delivery cavities extending axially and being centrosymmetric, and the two sets of control members are movably disposed in the two sets of delivery cavities, respectively.

The conveying device comprises a conveying sheath tube and a control piece, wherein the control piece comprises a control handle, a connector connected with a proximal clamping piece of the valve clamp and a control rod used for connecting the control handle and the connector, and the control rod and the connector can be driven to move by controlling the control handle so as to drive the proximal clamping piece connected with the connector to retract or expand relative to the fixing seat, so that conveying and fixing of the valve clamp are realized. Wherein, the control rod sets up in carrying the sheath intraductal, can avoid human tissue's extrusion, when utilizing the control handle to drive the control rod and remove, frictional resistance is little, and the control rod removes conveniently and is difficult for damaging human tissue, and in addition, control rod intensity is high, is difficult for the fracture in the use, and the reliability is high. Further, the control rod comprises a hollow tube and an inserted rod movably penetrating through the hollow tube, the control handle is connected to one ends of the hollow tube and the inserted rod, the connector is detachably connected to the other end of the hollow tube, after the valve clamp is installed in place, the control handle is used for driving the hollow tube and the inserted rod to move, the connection between the connector and the hollow tube can be rapidly disconnected, and therefore the connection between the delivery sheath tube, the control rod and the control handle and the valve clamp can be directly disconnected, and the operation difficulty is small, rapid and convenient. By adopting the conveying device to convey and adjust the valve clamp, the operation time can be effectively shortened, and the success rate of the operation can be improved.

In a second aspect, the present invention discloses a valve clamping system comprising a valve clamp and a delivery device as described in the first aspect.

In the valve clamping system provided by the embodiment, the conveying device comprises a sheath tube and an operating piece, the operating piece comprises an operating handle, a connector connected to a proximal clamping piece of the valve clamping device and a control rod used for connecting the operating handle and the connector, the control rod and the connector can be driven to move by controlling the operating handle, and then the proximal clamping piece connected to the connector can be driven to furl or unfold relative to the fixing seat, so that the conveying and fixing of the valve clamping device are realized. Wherein, the control rod sets up in carrying the sheath intraductal, can avoid human tissue's extrusion, when utilizing the control handle to drive the control rod and remove, frictional resistance is little, and the control rod removes conveniently and is difficult for damaging human tissue, and in addition, control rod intensity is high, is difficult for the fracture in the use, and the reliability is high. Further, the control rod comprises a hollow tube and an inserted rod movably penetrating through the hollow tube, the control handle is connected to one ends of the hollow tube and the inserted rod, the connector is detachably connected to the other end of the hollow tube, after the valve clamp is installed in place, the control handle is used for driving the hollow tube and the inserted rod to move, the connection between the connector and the hollow tube can be rapidly disconnected, and therefore the connection between the delivery sheath tube, the control rod and the control handle and the valve clamp can be directly disconnected, and the operation difficulty is small, rapid and convenient. By adopting the conveying device to convey and adjust the valve clamp, the operation time can be effectively shortened, and the success rate of the operation can be improved.

Drawings

In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic diagram of a valve clasper system provided in an embodiment of the present invention;

FIG. 2 is a schematic view of a delivery device and a valve clip according to an embodiment of the present invention;

FIG. 3 is a schematic view of the control lever and the connector shown in FIG. 2;

FIG. 4 is a second schematic view of the control lever and the connector shown in FIG. 2;

FIG. 5 is a schematic view of the connector and the proximal clip shown in FIG. 2;

fig. 6 is a schematic structural view of a delivery device and a valve clip according to a second embodiment of the present invention;

FIG. 7 is a schematic view of the control lever and the connecting head shown in FIG. 6;

FIG. 8 is a second schematic view of the control lever and the connector shown in FIG. 6;

FIG. 9 is a schematic view of the connector and proximal clip shown in FIG. 6;

FIG. 10 is a schematic view of a proximal clip and a holder of a valve clip according to an embodiment of the present invention;

FIG. 11 is a schematic view of a proximal clip and a holder of a valve clip according to an embodiment of the present invention;

fig. 12 is a schematic structural view of a fixing plate of a conveying device according to an embodiment of the present invention.

Description of main reference numerals:

1. a valve clasper system;

100. a conveying device;

10. a delivery sheath;

20. an operation control; 21. a control lever; 211. a hollow tube; 2111. a second connecting portion; 21111. a spring plate; 21112. a second half pipe; 212. a rod; 22. a control handle; 23. a connector; 231. a first connection portion; 2311. a first half pipe; 232. a fixing ring; 24. a fixing plate; 241. positioning holes; 242. a mounting hole;

300. a valve clip; 31. a fixing seat; 32. a proximal clip; 321. a connection hole; 322. a hook; 33. a distal clip.

Detailed Description

The present invention will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.

It will be understood that when an element is referred to as being "mounted" or "disposed" on another element, it can be directly or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly or indirectly connected to the other element. The terms "upper," "lower," "left," "right," and the like are used for convenience of description based on the orientation or positional relationship shown in the drawings, and do not denote or imply that the devices or elements in question must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be construed as limiting of the patent. The terms "first," "second," and "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features. The meaning of "a plurality of" is two or more, unless specifically defined otherwise.

In a first aspect, the present invention provides a delivery device for delivering a valve clip into a patient and controlling the retraction or deployment of a proximal clip of the valve clip relative to its anchor seat to secure the valve clip in a target position.

Embodiment one:

referring to fig. 1 to 5, a delivery device 100 according to the present embodiment includes a delivery sheath 10 and a manipulation member 20. The delivery sheath 10 includes a connecting end, which refers to an end distal from the operator for connecting to the valve clamp 300, and a manipulation end, which refers to an end proximal to the operator, distal from the valve clamp 300. As shown in fig. 1 and fig. 2, the control member 20 includes a control rod 21, a control handle 22 and a connector 23, the control rod 21 is movably disposed in the delivery sheath 10 in a penetrating manner and can move in the delivery sheath 10 along the extending direction of the delivery sheath 10, as shown in fig. 3 and fig. 4, the control rod 21 includes a hollow tube 211 and a plunger 212 movably disposed in the hollow tube 211, as shown in fig. 1, fig. 2 and fig. 4, the control handle 22 is connected to one end of the hollow tube 211 and the plunger 212 and extends from the control end of the delivery sheath 10, and the connector 23 is detachably connected to the other end of the hollow tube 211. The connector 23 is used for connecting the proximal clip 32, the control lever 21 is used for connecting the control handle 22 with the connector 23, and the control handle 22 is used for driving the hollow tube 211 and the insert rod 212 to move so as to connect or disconnect the connector 23 with the hollow tube 211 and to enable the proximal clip 32 to be folded or unfolded relative to the fixing seat 31. Specifically, when the connector 23 is connected to the hollow tube 211, the control handle 22 is used to drive the hollow tube 211 and the plunger 212 to move toward the control end close to the delivery sheath 10, so that the proximal clip 32 can be folded relative to the fixing seat 31; the proximal clip 32 can be deployed relative to the mounting base 31 by the handle 22 moving the hollow tube 211 and the plunger 212 toward the end of the delivery sheath 10 away from the handle.

It should be noted that, after the above-mentioned delivery device 100 is used to deliver and fix the valve clamp 300 and the valve clamp 300 is fixed at the target position, the main body portion of the delivery device 100 needs to be detached from the valve clamp 300 and removed from the body, where the main body portion of the delivery device 100 includes the delivery sheath 10, the control rod 21 and the control handle 22. In addition, as shown in fig. 2 and 10, the free end of the proximal clip 32 of the conventional valve clip 300 is provided with a connection hole 321, and the connector 23 of the delivery device 100 can be connected to the connection hole 321. In addition, the control rod 21 is a flexible rod, and the control rod 21 can conform to the deformation and the rotation angle of the proximal clip 32 to generate a certain degree of deformation in the process of controlling the proximal clip 32 to be folded or unfolded by using the control member 20, so as to avoid the swing of the delivery sheath 10 and the delivery device 100. In addition, the valve clip 300 further includes a distal clip 33, the proximal clip 32 and the distal clip 33 cooperate to form a clamp for clamping the valve leaflet, and the structures of the distal clip 33 and the like are not directly connected to the delivery device 100, and are not described in detail herein.

The conveying device 100 provided by the invention comprises a conveying sheath 10 and a control piece 20, wherein the control piece 20 comprises a control handle 22, a connector 23 connected with a proximal clamping piece 32 of a valve clamp 300 and a control rod 21 used for connecting the control handle 22 and the connector 23, and the control rod 21 and the connector 23 can be driven to move by controlling the control handle 22 so as to drive the proximal clamping piece 32 connected with the connector 23 to fold or unfold relative to a fixed seat 31, thereby realizing conveying and fixing of the valve clamp 300. Wherein, control rod 21 sets up in carrying sheath 10, can avoid the extrusion of human tissue, when utilizing control handle 22 to drive control rod 21 and remove, frictional resistance is little, and control rod 21 removes conveniently and is difficult for damaging human tissue, and in addition, control rod 21 intensity is high, is difficult for the fracture in the use, and the reliability is high. Further, the control rod 21 comprises a hollow tube 211 and an inserting rod 212 movably penetrating through the hollow tube 211, the control handle 22 is connected to the hollow tube 211 and one end of the inserting rod 212, the connector 23 is detachably connected to the other end of the hollow tube 211, after the valve clamp 300 is installed in place, the control handle 22 is utilized to drive the hollow tube 211 and the inserting rod 212 to move, the connection between the connector 23 and the hollow tube 211 can be rapidly disconnected, and therefore the connection between the delivery sheath 10, the control rod 21 and the control handle 22 and the valve clamp 300 can be directly disconnected, and the operation difficulty is small, rapid and convenient. The valve clamp 300 is conveyed and regulated by the conveying device 100, so that the operation time can be effectively shortened, and the success rate of the operation can be improved.

It will be appreciated that after the valve clip 300 is in place, the main body portion of the delivery device 100 needs to be removed from the body, so as to reduce damage to human tissue caused by friction during the taking and placing of the delivery device 100, and ensure that the outer wall surface of the delivery sheath 10 is smooth.

In this embodiment, as shown in fig. 1, 2 and 3, the connector 23 includes a first connecting portion 231, the control rod 21 includes a second connecting portion 2111, and the control handle 22 is used to drive the plunger 212 to move in the first connecting portion 231 and the second connecting portion 2111, so as to connect or disconnect the hollow tube 211 with the connector 23.

Further, as shown in fig. 1, 3 and 4, the first connection portion 231 is a hollow connection pipe head, and the second connection portion 2111 is an elastic arm disposed at one end of the hollow pipe 211 connected to the connection head 23, and the elastic arm can extend into the connection pipe head and be clamped with the connection pipe head. The control handle 22 is used for controlling the insert rod 212 to move along the axial direction of the hollow tube 211 so as to switch the insert rod 212 between a locking state and a switching state, wherein, as shown in fig. 4, when the insert rod 212 is in the locking state, the insert rod 212 stretches into between the elastic arms and abuts against the elastic arms, so that the elastic arms are clamped between the insert rod 212 and the connecting tube head, and the elastic arms are clamped with the connecting tube head, thereby realizing the connection between the connecting tube 23 and the hollow tube 211; as shown in fig. 3, when the plunger 212 is in the unlocked state, the plunger 212 is pulled out from between the elastic arms and away from the elastic arms, and the elastic arms return to the natural state and are released from the connection head 23 in the radial direction of the connection head, so that the elastic arms and the connection head can be separated in the axial direction of the plunger 212. It will be appreciated that to ensure a secure effect of the plunger 212, the axial cross-section of the plunger 212 is sized slightly smaller than the inner diameter of the coupling head. By adopting the design, the assembly and disassembly of the control rod 21 and the connector 23 can be completed by moving the hollow tube 211 and the inserted rod 212, the structure is simple, the use is convenient, and the quick assembly and disassembly of the control rod 21 and the connector 23 can be realized; in addition, when the connector 23 is connected to the hollow tube 211, the connection is firm and the connector is not easy to fall off.

Further, in this embodiment, as shown in fig. 3 and 4, the elastic arm includes two opposite elastic sheets 21111, and along the direction pointing to the free ends of the elastic sheets 21111, the two elastic sheets 21111 are in a tapered structure, i.e. the gap between the two elastic sheets 21111 is gradually reduced, and the size of the free ends of the elastic arm is smaller than the inner diameter of the connecting pipe head. The inserting rod 212 can extend into between the two elastic sheets 21111 and is abutted against the inner wall of the elastic sheet 21111, so that the elastic sheet 21111 is abutted against the inner wall of the connecting tube head. By adopting the design, the free end of the elastic arm is small in size, and the elastic arm and the connecting pipe head are convenient to assemble; in addition, the elastic sheet 21111 has simple structure, strong deformability, good connection and fixation effect with the connecting tube head and difficult damage.

In order to improve the reliability of the conveying device 100, in this embodiment, as shown in fig. 2, 3 and 4, a first clamping structure is disposed on the inner wall of the connecting tube head, and a second clamping structure that is matched and clamped with the first clamping structure is disposed on the outer wall of the elastic sheet 21111. After the elastic arm is inserted into the connecting tube head, the positions of the first clamping structure and the second clamping structure are opposite, and when the inserting rod 212 is in a locking state, the first clamping structure and the second clamping structure are oppositely clamped, so that the position of the elastic arm and the connecting tube head in the axial direction of the inserting rod 212 is limited. By adopting the design, the connection fixing effect of the elastic arm and the connecting pipe head can be further improved, the falling risk of the connecting head 23 in the using process of the conveying device 100 is reduced, and the reliability of the conveying device 100 can be improved.

Alternatively, as shown in fig. 3 and 4, the first connection structure is a clamping groove, and the second connection structure is a flange that is in fit and clamping connection with the clamping groove. When the elastic arm is in a natural state, the flange on the elastic arm is kept separate from the clamping groove on the connecting pipe head.

In this embodiment, as shown in fig. 2, 5 and 10, the connector 23 includes a fixing ring 232 connected to the proximal clip 32, and the fixing ring 232 is disposed through the connecting hole 321 of the proximal clip 32. The fixing ring 232 is used for connecting the conveying device 100 and the proximal clamping piece 32, the connecting effect is good, the connector 23 is not easy to fall off from the proximal clamping piece 32 in the use process, and the reliability is high. It will be appreciated that in some embodiments, to facilitate coupling the proximal clip 32 to the retaining ring 232, a hook 322 may also be provided on the proximal clip 32, as shown in fig. 11.

It will be appreciated that in some embodiments, the connector 23 includes a claw attached to the proximal clip 32.

In this embodiment, the delivery sheath 10 is a multi-lumen tube, and multiple sets of delivery lumens are included in the delivery sheath 10. Optionally, the delivery device 100 includes two sets of manipulating members 20, the delivery sheath 10 includes two sets of delivery lumens extending along an axial direction thereof, and the two sets of manipulating members 20 are movably disposed in the two sets of delivery lumens, respectively. The conventional valve clip 300 includes two sets of proximal clips 32, each set of proximal clips 32 being correspondingly coupled to one set of operating members 20, the two sets of proximal clips 32 being independently controllable by the two sets of operating members 20. By adopting the design, each group of control pieces 20 are independently arranged in a conveying cavity, the independence is high, when the control pieces 20 are utilized to adjust the opening of the proximal clamping piece 32, the multiple groups of control pieces 20 cannot cross and interfere with each other, the conveying device 100 is not easy to damage, and the precise adjustment of the opening and closing angles of the proximal clamping piece 32 is convenient to realize, and the reliability is high.

Optionally, in the delivery sheath 10, two sets of delivery cavities are centrally and symmetrically arranged, so that when the opening and closing of the proximal clamping piece 32 is adjusted by the control piece 20, the radial stress of the delivery sheath 10 is uniform, which is beneficial to the balance of the delivery sheath 10, thereby effectively avoiding the swing of the delivery sheath 10 and the delivery device 100 and reducing the damage to patients in the operation process.

Further, as shown in fig. 1, 2 and 12, the connecting end of the delivery sheath 10 is further provided with a fixing plate 24, and the fixing plate 24 is provided with a positioning hole 241 which is communicated with the delivery cavity and is used for the control rod 21 to pass through. By adopting the structure, the position of the control rod 21 can be better positioned, when the operation pieces 20 are used for adjusting the opening of the proximal clamping pieces 32, the multiple operation pieces 20 cannot be crossed or interfered with each other, and the accuracy of the position adjustment of the proximal clamping pieces 32 can be further improved.

It should be noted that, as shown in fig. 2 and 12, the delivery sheath 10 further includes a receiving cavity, and the fixing plate 24 is provided with a mounting hole 242 communicated with the receiving cavity, where the receiving cavity is used for mounting a locking structure or other connection structure of the valve clip 300.

In this embodiment, the steering handle 22 extends from the wall of the steering end of the delivery sheath 10. The conveying sheath 10 has larger installation space on the wall, is convenient for installing the control handle 22, and the control handle 22 is installed on the wall, thereby being convenient to use.

It will be appreciated that in some embodiments, the steering handle 22 may also be mounted on the end of the delivery sheath 10, and may be specifically designed according to the actual situation, and is not limited herein.

In this embodiment, the connector 23 is made of stainless steel. The stainless steel material has the advantages of high strength, good corrosion resistance, good welding performance, smooth surface and the like, the connector 23 prepared from the stainless steel material has high strength, is not easy to deform and break in the use process, is easy to clean, can be repeatedly used for many times, and has high practicability and reliability.

It will be appreciated that in some embodiments, the connector 23 may be made of cobalt alloy, titanium alloy or other metal materials, which may be designed according to practical situations, provided that the installation requirements and the strength requirements are met, and the invention is not limited thereto.

In this embodiment, the insert 212 is made of nitinol. The nickel-titanium alloy has the advantages of low density, no magnetism, no toxicity, high strength and the like, and the inserted bar 212 prepared by the nickel-titanium alloy has high strength, light weight, difficult deformation and damage in the use process, easy pulling and convenient use.

It will be appreciated that, in some embodiments, the insert rod 212 may be made of stainless steel, titanium alloy, resin or plastic, which is not limited herein, as long as the requirements of use and strength are met.

In one embodiment, hollow tube 211 is a metallic hypotube. The metal hypotube has the advantages of high flexibility, high torsion resistance, good shrinkage resistance and the like, and when the metal hypotube is used, the metal hypotube can conform to the deformation of the proximal clamping piece 32 and the deformation of the rotation angle to a certain extent, and can resist the extrusion of human tissues, so that the normal use of the inserted rod 212 can be ensured, and the reliability is high.

It will be appreciated that in some embodiments, the hollow tube 211 may be a composite tube with a woven mesh, provided that the requirements of use and strength are met, and the design may be specifically based on practical situations, and is not limited herein.

In one embodiment, the length of hollow tube 211 is greater than the length of plunger 212. By adopting the design, the structure is reasonable, and in the adjusting process, the inserted bar 212 always moves in the hollow tube 211 and is not easy to damage.

It will be appreciated that, in some embodiments, the length of the insert rod 212 may be greater than or equal to the length of the hollow tube 211 for easy handling or assembly, and the design may be specifically designed according to practical situations, and is not limited herein.

The delivery device 100 provided by the present invention is useful in valve repair procedures including, but not limited to, valve repair of mitral valve, valve repair of tricuspid valve. In the following, a mitral valve repair will be described as an example, and a specific method of using the delivery device 100 according to the present invention is as follows: firstly, a fixing ring 232 of a connector 23 is installed on a proximal clamping piece 32 of a valve clamp 300, an elastic arm of a hollow tube 211 is inserted into a connecting tube head of the connector 23, a control handle 22 is pulled to drive an inserting rod 212 to move towards one side of the elastic arm and the connecting tube head, and the elastic arm and the connecting tube head are locked, so that the fixed connection between a conveying device 100 and the valve clamp 300 is realized; then, the valve clamp 300 is conveyed to the position of the mitral valve in the patient by utilizing the conveying device 100, after the valve clamp 300 reaches the target position, the control handle 22 is pulled to drive the control rod 21 and the connector 23 to move back and forth towards one side close to or far away from the control end, so that the angle adjustment of the proximal clamping piece 32 is realized, and the valve clamp 300 clamps the mitral valve leaflet; then, the control handle 22 is pulled to drive the control rod 21 and the connector 23 to move towards the side close to the control end until the proximal clamping piece 32 is closed relative to the fixed seat 31, so that the valve clamp 300 is completely folded; then, the control handle 22 is pulled to drive the inserted rod 212 to move towards the side far away from the elastic arm and the connecting pipe head, so that the elastic arm and the connecting pipe head are unlocked, and the control handle 22 is pulled continuously to drive the control rod 21 and the inserted rod 212 to move towards the side far away from the connecting pipe head and the proximal clamping piece 32, so that the control rod 21 is separated from the connecting head 23 and the proximal clamping piece 32; the body portion of the delivery device 100 is then removed and the valve clip 300 and connector 23 are left in the patient.

Embodiment two:

referring to fig. 6-9, a delivery device 100 according to the present embodiment includes a delivery sheath 10 and a manipulation member 20. As shown in fig. 1 and 6, the delivery sheath 10 includes a connection end and a control end, the control member 20 includes a control rod 21, a control handle 22 and a connector 23, and the control rod 21 is movably disposed in the delivery sheath 10 and is movable in the delivery sheath 10 along the extending direction of the delivery sheath 10. As shown in fig. 7 and 8, the control rod 21 includes a hollow tube 211 and a plunger 212 movably inserted into the hollow tube 211, and as shown in fig. 1, 6 and 8, the control handle 22 is connected to one end of the hollow tube 211 and the plunger 212 and protrudes from the control end of the delivery sheath 10, and the connector 23 is detachably connected to the other end of the hollow tube 211. The connector 23 is used for connecting the proximal clip 32, the control lever 21 is used for connecting the control handle 22 with the connector 23, and the control handle 22 is used for driving the hollow tube 211 and the insert rod 212 to move so as to connect or disconnect the connector 23 with the hollow tube 211 and to enable the proximal clip 32 to be folded or unfolded relative to the fixing seat 31.

In this embodiment, as shown in fig. 1, 7 and 8, the connector 23 includes a first connecting portion 231, the control rod 21 includes a second connecting portion 2111, and the control handle 22 is used to drive the plunger 212 to move in the first connecting portion 231 and the second connecting portion 2111, so as to connect or disconnect the hollow tube 211 with the connector 23.

Further, as shown in fig. 1, 7 and 8, the first connecting portion 231 is a first half pipe 2311, the second connecting portion 2111 is a second half pipe 21112, the edges of the first half pipe 2311 and the second half pipe 21112 are respectively formed with a limit groove and a limit flange capable of being engaged and clamped, the first half pipe 2311 and the second half pipe 21112 are combined to form a hollow pipe structure, and the limit groove and the limit flange are engaged along the axial direction of the hollow pipe; the control handle 22 is used for controlling the plunger 212 to move along the axial direction of the hollow tube 211 so as to switch the plunger 212 between a locking state and a switching state, wherein, as shown in fig. 8, when the plunger 212 is in the locking state, the plunger 212 extends into the hollow tube formed by the first half tube 2311 and the second half tube 21112 in an abutting manner, and the first half tube 2311 and the second half tube 21112 are locked along the radial direction of the plunger 212; as shown in fig. 7, when the plunger 212 is in the unlocked state, the plunger 212 is away from the first half pipe 2311 and the second half pipe 21112, and the first half pipe 2311 and the second half pipe 21112 are separable in the radial direction of the plunger 212. It will be appreciated that to ensure a secure fit of the plunger 212, the axial cross-section of the plunger 212 is sized slightly smaller than the inner diameter of the hollow tube formed by the apposition of the first half tube 2311 and the second half tube 21112. By adopting the design, the assembly and disassembly of the control rod 21 and the connector 23 can be completed by moving the hollow tube 211 and the inserted rod 212, the structure is simple, the use is convenient, and the quick assembly and disassembly of the control rod 21 and the connector 23 can be realized; in addition, when the connector 23 is connected to the hollow tube 211, the connection is firm and the connector is not easy to fall off.

Further, in the present embodiment, as shown in fig. 7 and 8, the edges of the first half pipe 2311 and the second half pipe 21112 have a rounded S-shaped structure. With the above design, the first half pipe 2311 and the second half pipe 21112 are convenient to assemble, and are not easy to deform and damage in the assembling process.

The delivery device 100 provided by the present invention is useful in valve repair procedures including, but not limited to, valve repair of mitral valve, valve repair of tricuspid valve. In the following, a mitral valve repair will be described as an example, and a specific method of using the delivery device 100 according to the present invention is as follows: firstly, the fixing ring 232 of the connector 23 is mounted on the proximal clip 32 of the valve clamp 300, and the first half tube 2311 and the second half tube 21112 are combined to form a hollow tube, so as to drive the inserting rod 212 to move towards one side of the first half tube 2311 and the second half tube 21112, and lock the first half tube 2311 and the second half tube 21112, thereby realizing the fixed connection of the delivery device 100 and the valve clamp 300; then, the valve clamp 300 is conveyed to the position of the mitral valve in the patient by utilizing the conveying device 100, after the valve clamp 300 reaches the target position, the control handle 22 is pulled to drive the control rod 21 and the connector 23 to move back and forth towards one side close to or far away from the control end, so that the angle adjustment of the proximal clamping piece 32 is realized, and the valve clamp 300 clamps the mitral valve leaflet; then, the control handle 22 is pulled to drive the control rod 21 and the connector 23 to move towards the side close to the control end until the proximal clamping piece 32 is closed relative to the fixed seat 31, so that the valve clamp 300 is completely folded; then, pulling the control handle 22 drives the plunger 212 to move towards the side far from the first half pipe 2311 and the second half pipe 21112, so that the first half pipe 2311 and the second half pipe 21112 are unlocked, and continuing to pull the control handle 22 drives the plunger 21 and the plunger 212 to move towards the side far from the connecting pipe head and the proximal clamping piece 32, so that the plunger 21 is separated from the connecting head 23 and the proximal clamping piece 32; the body portion of the delivery device 100 is then removed and the valve clip 300 and connector 23 are left in the patient.

Embodiment III:

as shown in fig. 1 and 2, the delivery device 100 provided in this embodiment includes a delivery sheath 10 and a manipulation member 20. As shown in fig. 1 and 6, the delivery sheath 10 includes a connection end and a control end, the control member 20 includes a control rod 21, a control handle 22 and a connector 23, and the control rod 21 is movably disposed in the delivery sheath 10 and is movable in the delivery sheath 10 along the extending direction of the delivery sheath 10. As shown in fig. 7 and 8, the control rod 21 includes a hollow tube 211 and a plunger 212 movably inserted into the hollow tube 211, and as shown in fig. 1, 6 and 8, the control handle 22 is connected to one end of the hollow tube 211 and the plunger 212 and protrudes from the control end of the delivery sheath 10, and the connector 23 is detachably connected to the other end of the hollow tube 211. The connector 23 is used for connecting the proximal clip 32, the control lever 21 is used for connecting the control handle 22 with the connector 23, and the control handle 22 is used for driving the hollow tube 211 and the insert rod 212 to move so as to connect or disconnect the connector 23 with the hollow tube 211 and to enable the proximal clip 32 to be folded or unfolded relative to the fixing seat 31.

In this embodiment, the connector 23 includes a connecting head having a hollow interior and an inner diameter equal to that of the hollow tube 211, and a threaded structure is disposed on an inner wall of the connecting head, an inner wall of the hollow tube 211 connected to one end of the connecting head, and an outer wall of the insert 212. The insert rod 212 is rotated by the control handle 22, so that one end of the insert rod 212 extends into the connecting tube head, and the hollow tube 211 and the connecting head 23 can be connected in series with the insert rod 212, thereby realizing the connection and fixation of the hollow tube 211 and the connecting head 23; the hollow tube 211 and the connector 23 can be disconnected by rotating the plunger 212 with the control handle 22 to separate the plunger 212 from the connector 23.

The delivery device 100 provided by the present invention is useful in valve repair procedures including, but not limited to, valve repair of mitral valve, valve repair of tricuspid valve. In the following, a mitral valve repair will be described as an example, and a specific method of using the delivery device 100 according to the present invention is as follows: firstly, a fixing ring 232 of a connector 23 is installed on a proximal clamping piece 32 of a valve clamp 300, a connecting tube head of a hollow tube 211 and a connecting tube head of the connector 23 are combined, an inserting rod 212 is driven to move towards one side of the connector 23, and the hollow tube 211 and the connector 23 are locked with the inserting rod 212, so that the conveying device 100 is fixedly connected with the valve clamp 300; then, the valve clamp 300 is conveyed to the position of the mitral valve in the patient by utilizing the conveying device 100, after the valve clamp 300 reaches the target position, the control handle 22 is pulled to drive the control rod 21 and the connector 23 to move back and forth towards one side close to or far away from the control end, so that the angle adjustment of the proximal clamping piece 32 is realized, and the valve clamp 300 clamps the mitral valve leaflet; then, the control handle 22 is pulled to drive the control rod 21 and the connector 23 to move towards the side close to the control end until the proximal clamping piece 32 is closed relative to the fixed seat 31, so that the valve clamp 300 is completely folded; then, the control handle 22 is pulled to drive the inserted rod 212 to move towards the side far away from the connector 23, so that the hollow tube 211 and the connector 23 are unlocked with the inserted rod 212, and the control handle 22 is pulled continuously to drive the control rod 21 and the inserted rod 212 to move towards the side far away from the connector head and the proximal clamping piece 32, so that the control rod 21 is separated from the connector 23 and the proximal clamping piece 32; the body portion of the delivery device 100 is then removed and the valve clip 300 and connector 23 are left in the patient.

In a second aspect, referring to fig. 1-12, the present invention also provides a valve clamping system 1 comprising a valve clamp 300 and a delivery device 100. As shown in fig. 1, 2 and 6, the delivery sheath 10 includes a connection end and a manipulation end, wherein the connection end refers to an end distal from the operator for connecting the valve clamp 300, and the manipulation end refers to an end proximal to the operator and distal from the valve clamp 300. As shown in fig. 1, 2 and 6, the control member 20 includes a control rod 21, a control handle 22 and a connector 23, where the control rod 21 movably penetrates through the delivery sheath 10 and can move in the delivery sheath 10 along the extending direction of the delivery sheath 10, as shown in fig. 3 and 4, and as shown in fig. 1, 2 and 4, the control rod 21 includes a hollow tube 211 and a plug 212 movably penetrating through the hollow tube 211, and as shown in the drawings, the control handle 22 is connected to one end of the hollow tube 211 and the plug 212 and extends from the control end of the delivery sheath 10, and the connector 23 is detachably connected to the other end of the hollow tube 211. The connector 23 is used for connecting the proximal clip 32, the control lever 21 is used for connecting the control handle 22 with the connector 23, and the control handle 22 is used for driving the hollow tube 211 and the insert rod 212 to move so as to connect or disconnect the connector 23 with the hollow tube 211 and to enable the proximal clip 32 to be folded or unfolded relative to the fixing seat 31. Specifically, when the connector 23 is connected to the hollow tube 211, the control handle 22 is used to drive the hollow tube 211 and the plunger 212 to move toward the control end close to the delivery sheath 10, so that the proximal clip 32 can be folded relative to the fixing seat 31; the proximal clip 32 can be deployed relative to the mounting base 31 by the handle 22 moving the hollow tube 211 and the plunger 212 toward the end of the delivery sheath 10 away from the handle.

In the valve clamping system 1 provided in this embodiment, the conveying device 100 includes a sheath tube and an operating member 20, the operating member 20 includes an operating handle 22, a connector 23 connected to a proximal clamping piece 32 of the valve clamp 300, and a control rod 21 for connecting the operating handle 22 and the connector 23, and the operating handle 22 can drive the control rod 21 and the connector 23 to move, so as to drive the proximal clamping piece 32 connected to the connector 23 to retract or expand relative to the fixing seat 31, thereby realizing conveying and fixing of the valve clamp 300. Wherein, control rod 21 sets up in carrying sheath 10, can avoid the extrusion of human tissue, when utilizing control handle 22 to drive control rod 21 and remove, frictional resistance is little, and control rod 21 removes conveniently and is difficult for damaging human tissue, and in addition, control rod 21 intensity is high, is difficult for the fracture in the use, and the reliability is high. Further, the control rod 21 comprises a hollow tube 211 and an inserting rod 212 movably penetrating through the hollow tube 211, the control handle 22 is connected to the hollow tube 211 and one end of the inserting rod 212, the connector 23 is detachably connected to the other end of the hollow tube 211, after the valve clamp 300 is installed in place, the control handle 22 is utilized to drive the hollow tube 211 and the inserting rod 212 to move, the connection between the connector 23 and the hollow tube 211 can be rapidly disconnected, and therefore the connection between the delivery sheath 10, the control rod 21 and the control handle 22 and the valve clamp 300 can be directly disconnected, and the operation difficulty is small, rapid and convenient. The valve clamp 300 is conveyed and regulated by the conveying device 100, so that the operation time can be effectively shortened, and the success rate of the operation can be improved.

As shown in fig. 2, 5 and 10, the proximal clip 32 of the valve clip 300 provided in this embodiment is provided with a connection hole 321, and the connection hole 321 can be fastened with a hook, a fixing ring 232, and other structures. The proximal clip 32 is made of an elastic material, for example, nickel titanium, stainless steel, polymer, or the like. Alternatively, the proximal clip 32 is fabricated from a nickel titanium material.

The above embodiments are only for illustrating the technical solution of the present application, and are not limiting; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present application, and are intended to be included in the scope of the present application.

Claims

1. A delivery device for delivering a valve clip, the valve clip comprising a holder and a proximal clip disposed on the holder, the delivery device comprising:

the conveying sheath tube comprises a connecting end and a control end;

2. The delivery device of claim 1, wherein the connector comprises a first connection portion, the control rod comprises a second connection portion, and the control handle is configured to drive the plunger to move within the first connection portion and the second connection portion to connect or disconnect the hollow tube to the connector.

3. The conveying device according to claim 2, wherein the first connecting part is a connecting pipe head with a hollow interior, the second connecting part is an elastic arm arranged at one end of the hollow pipe connected with the connecting head, and the elastic arm can extend into the connecting pipe head and be clamped with the connecting pipe head;

4. A delivery device according to claim 3, wherein the resilient arm comprises two oppositely disposed spring plates, the spring plates being tapered in a direction pointing towards the free ends of the spring plates;

5. The conveying device according to claim 4, wherein a first clamping structure is arranged on the inner wall of the connecting tube head, and a second clamping structure matched and clamped with the first clamping structure is arranged on the outer wall of the elastic piece.

6. The conveying device according to claim 2, wherein the first connecting portion is a first half pipe, the second connecting portion is a second half pipe, a limit groove and a limit flange capable of being matched and clamped are formed at the edges of the first half pipe and the second half pipe respectively, a hollow pipe structure is formed after the first half pipe and the second half pipe are combined, and the limit groove and the limit flange are clamped along the axial direction of the hollow pipe;

7. The delivery device of claim 6, wherein edges of the first half tube and the second half tube are smoothly transitioned S-shaped structures.

8. The delivery device of any of claims 1-7, wherein the connector includes a securing ring for connecting the proximal clip.

9. The delivery device of any one of claims 1-7, wherein the delivery device comprises two sets of the manipulation members, the delivery sheath comprises two sets of delivery lumens extending axially along the delivery sheath and being centrally symmetrical, and the two sets of the manipulation members are movably disposed within the two sets of delivery lumens, respectively.

10. A valve clamping system comprising a valve clamp and a delivery device according to any one of claims 1-9.